Conformance of Design History Files for Mature Medical Devices 2015
16 Sep 2015
Webinar
Description
Topics
Set procedures and template to complete remediation for design history file of old devices to meet current standards
Multi-functional team approach/responsibility
Data gathering to build the design history files
Gap analysis
Risk assessment for prioritizing remediation
Risk procedure
Dealing with the FDA
Validations
Phase by phase check list
Who should Attend
End-users responsible for design control and technical files that need to be updated to the current standards
Senior management
Process engineers and managers
R&D and product development
Validation engineers
Operations and plant management
Documentation teams
Remediation teams
QC and Corporate Auditors
QA, Regulatory Affairs
Consultants
All team members who contribute to design history, clinical, validations or technical files
All Contract Manufacturers working in the medical industry
Past Events
Conformance of Design History Files for Mature Medical Devices 2015 - 16 Sep 2015, Webinar (43199)
Important
Please, check "Conformance of Design History Files for Mature Medical Devices" official website for possible changes, before making any traveling arrangements
